Status:
COMPLETED
Flow Arrest Safety and Technical Success With Balloon Guide Catheters
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing tempor...
Detailed Description
This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial ...
Eligibility Criteria
Inclusion
- Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
- Adult patient willing to provide Informed Consent
- Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6
Exclusion
- Posterior circulation stroke
- Tandem occlusions
- Cervical carotid stenosis
- Participating in another clinical trial
Key Trial Info
Start Date :
January 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04416659
Start Date
January 12 2021
End Date
October 27 2021
Last Update
April 28 2022
Active Locations (9)
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1
BNI (St. Joseph's Hospital-Dignity Health)
Phoenix, Arizona, United States, 85013
2
Swedish-RIACO
Englewood, Colorado, United States, 80112
3
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
4
Northwestern University
Chicago, Illinois, United States, 60611